Effect of Colloid Versus Crystalloid on Coagulation

K. C. Rasmussen

Status and phase: Unknown; Phase 4

Conditions: Bloodloss

Treatments: Drug: HES 130/04; Drug: Ringer-lactate "SAD"

Study type: Interventional

Funder types: Other

Identifiers

NCT01444508

2011-003270-80

Details and patient eligibility

About

In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient more than 18 years old
• Indication for elective post-renal operation including cystectomy
• Patient without anticoagulative, acetylsalicylic acid or NSAID treatment for the last 5 days.

Exclusion criteria

• Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
• Pregnant or nursing
• Allergic
• Disturbance in electrolytes
• Patient under committee
• Patient joining another trial interfering the actual trial.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

crystalloid

Active Comparator group

Treatment:

Drug: Ringer-lactate "SAD"

colloid

Placebo Comparator group

Treatment:

Drug: HES 130/04